
Freyja HealthCare’s VereSee(TM) Device Receives 510(k) Clearance, the First of Many Products
Freyja Healthcare Brings First-of-Its-Kind 2mm Abdominal-Access Device to Laparoscopic Surgery to Further Innovation in Fast-Growing Women’s Health Market

Freyja Healthcare Brings First-of-Its-Kind 2mm Abdominal-Access Device to Laparoscopic Surgery to Further Innovation in Fast-Growing Women’s Health Market

Lumicell developed the technology to help physicians detect residual cancer in the breast cavity after surgery.

Lumicell today announced it received FDA approval for its LumiSystem direct visualization system for breast cancer removal.

Highmark BCBS and BCBS of North Dakota cover the Leva Pelvic Health System for women seeking effective treatment for urinary incontinence

The Food and Drug Administration (FDA) has approved the Investigational Device Exemption (IDE) of the Lumerah™ technology for the early detection of fetal distress during labor and delivery.

Siemens Healthineers announced today that it received FDA 510(k) clearance for its MammoMat B.brilliant mammography platform.

Benefits of the system, according to a news release, include maneuverability and visualization.

FixNip NRI is a nipple implant for women who have undergone breast reconstruction surgery

One panelist who voted yes said the “incremental benefits outweigh the small risks of anaphylaxis.”

Roche Diagnostics has announced CE mark approval for a claim extension to the Elecsys Anti-Müllerian Hormone (AMH) Plus immunoassay. The claim extension means that the blood test, already available on the NHS, can now be used by physicians to help diagnose women suspected of having polycystic ovary syndrome (PCOS) as an alternative to a transvaginal ultrasound.